Treatment of Superficial Strawberry Birthmarks with Topical Timolol

Phase 2

Recruiting

• Conditions: Infantile Haemangioma; Skin - Dermatological conditions

• Registration Number: ACTRN12619001370190
• Lead Sponsor: Gillies McIndoe Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-08
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Infants referred with a superficial IH(s) in the cosmetic sensitive areas (face and neck), perineum, buttock and axilla, who are not suitable for oral propranolol treatment.

Exclusion Criteria

•Premature infants (less than 6 weeks corrected gestational age)
•IH on or near mucosal surface such as the eye, mouth and anus
•Any single lesion larger than 90mm² (e.g., 3x3cm)
•Multifocal IHs with a total surface area of more than 90mm²
•IH with ulceration >1x1cm
•IH with thickness >3mm
•Subcutaneous IH
•Any infants with contraindication to ß-blocker use, e.g.:
oCardiac disease including: 2nd or 3rd degree atrioventricular heart block, bradycardia, cardiac failure, cardiogenic shock and congenital heart disease
oCongenital hyperthyroidism
oHypersensitivity to any components of the medication
•Weight <3.5kg
•>10 months old
•Premature infants with a history of apnoea or chronic lung disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified